Intravenous n-3 Fatty Acids and Sudden Cardiac Death in Hemodialysis Patients

Phase 2

Completed

• Conditions: Renal Failure, Chronic

• Registration Number: NCT00259025
• Lead Sponsor: Aalborg University Hospital

Brief Summary

The main purpose of this study is to investigate whether intravenous infusion of a lipid emulsion with a high content of n-3 polyunsaturated fatty acids can improve heart rate variability and ventricular repolarization and reduce ventricular arrhythmias in hemodialysis patients.

Detailed Description

Cardiovascular disease is the most common cause of death in haemodialysis (HD)patients, and half of these deaths are due to sudden cardiac death caused by ventricular arrhythmias. HD patients have an attenuated heart rate variability (HRV) and a high frequency of ventricular arrhythmias, both of which are predictors of sudden cardiac death(SCD). n-3 polyunsaturated fatty acids (PUFA) improves HRV and reduces the risk of SCD. n-3 PUFAs are obtained from fatty fish and fish oil and are incorporated into cell membranes after long-term ingestion. However, it is not known if this incorporation is essential or merely serves as storage for n-3 free PUFAs to be release during for instance myocardial ischaemia.

The study hypothesis is that intravenous infusion of a lipid emulsion with a high content of n-3 PUFAs will improve HRV and ventricular repolarization and reduce ventricular arrhythmias via an acute increase in free non-esterified n-3 PUFAs in plasma.

In a randomized, placebo-controlled design a n-3 PUFA rich emulsion (or placebo) will be administered during hemodialysis treatment. The two study groups will be compared with respect to heart rate variability, ventricular repolarization parameters, ventricular ectopic beats and arrhythmias and the content of n-3 PUFA in plasma and cell membranes will be compared.

Study Timeline

• Study First Submitted: 2005-11-25
• Study First Submitted QC: 2005-11-25
• Study First Posted: 2005-11-29
• Study Start: 2006-09
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2008-04
• Last Update Submitted: 2008-08-08
• Last Update Posted: 2008-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age > 18 yrs
• End-stage renal failure
• Maintenance haemodialysis treatment > 3 months

Exclusion Criteria

• Allergy to fish or egg protein
• Body weight < 50 kgs
• Chronic supraventricular tachycardia
• Implanted pacemaker
• Myocardial infarction within 6 months
• PCI or CABG within 6 months
• Stroke or TIA within 6 months
• HbA1C > 10 %
• ALAT > 100 U/l
• Triglycerides > 3 mmol/l
• Ongoing infection
• Tendency to severe blood pressure drops during dialysis treatment
• Malignancy
• Psychiatric disorder
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Heart rate variability

Secondary Outcome Measures

Name	Time	Method
Ventricular repolarization, ventricular arrhythmias
n-3 polyunsaturated fatty acids in plasma and cell membranes

Trial Locations

Locations (1)

Department of Nephrology, Aalborg Hospital; 🇩🇰 Aalborg, Denmark